Working Globally

A global problem

Many of the pharmaceuticals that are purchased in the developing world are substandard or outright fake drugs. Although there is no global system for monitoring the quality of medicine, study after study reveals pervasive poor quality and products that are worthless or even harmful to patients. Many countries in the developing world do not have the technological infrastructure or regulatory resources to keep low quality medicines off the market shelves. And since the pharmaceutical trade is a lucrative global market, low quality medicine can cross borders and harm people anywhere in the world.

Root causes:

Negligence by manufacturers

A heart medicine called "Isotab" killed over 200 people in Pakistan when one batch was manufactured using toxic quantities of an antimalarial medicine in place of the inert filler that was supposed to be added. According to the Pakistani government's report (pathology_of_negligence_pic_drug_inquiry_report_2012.pdf) the antimalarial drug got wet during delivery, and was moved into a drum marked "starch". No-one ever changed the label or noticed the substitution.

Deliberate falsification by manufacturers or distributors

Fortune Magazine has a great investigatory report on Ranbaxy's contribution to this area.

Even secure supply chains fall victim; see this WHO report on testing company Semler Research faking bioequivalence studies.

New ways to find fake medicines

Paper analytical devices (PADs) are test cards that can quickly determine whether a drug tablet contains the correct medicines. They are cheap and easy to use. They don't require power, chemicals, solvents, or any expensive instruments, so they can be deployed rapidly at large scale whereever a problem with pharmaceutical quality is suspected.

Partnering with regulatory agencies

By sharing our results directly with medical regulatory agencies, we help them quickly discover poor quality medicines in their markets. This enables them to negotiate with manufacturers and distributors from a position of knowledge and to take other regulatory and legal actions to protect patients from poor quality products.

Bringing market forces to bear

In the developing world, most buyers have to trust what the seller tells them about the quality of the pharmaceuticals they purchase. Unscrupulous manufacturers and distributors know that there is little chance that their medicines will be screened in a lab. These paper test cards don't need a lab, and they will enable people all over the world to quickly detect low quality medicines and remove them from the market.

Notre Dame has licensed the PAD technology to Veripad, LLC. This startup company has developed a cell-phone based PAD reader that automatically analyzes the PAD image for the user. Watch for more developments!

The World Health Organisation (WHO) has recently published an advocacy document in attempt to quantify the cost and socio-economic impact of falsified and substandard medicines in low- and middle-income countries (link…